Three-Dimensional Assessment of Right Ventricular Function in Patients Undergoing Left Ventricular Assist Device Implantation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- University of Alberta
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Right ventricular fractional area of change
- Status
- Recruiting
- Last Updated
- 11 months ago
Overview
Brief Summary
This goal of this study is to analyze images of the right ventricle taken via 3D transesophageal echocardiography (TEE) during left ventricular assist device (LVAD) implantation.
Detailed Description
There are two chambers in the heart known as ventricles which are responsible for pumping blood to both the lungs and the rest of the body. The right ventricle pumps blood to the lungs for oxygenation. The left ventricle then delivers this oxygenated blood to the organs in the body. When the left ventricle is damaged enough that it is not able to effectively pump blood then it may be necessary to assist it with a mechanical pump. This pump is called left ventricular assist device (LVAD). Left ventricular assist devices (LVADs) improve quality of life and survival in patients with end stage heart failure. However, right ventricular (RV) failure is common in 20-50% of LVAD recipients and is associated with perioperative complications. Traditional two-dimensional ultrasound views of the right ventricle may not accurately depict how well or poorly the right ventricle is working. Three-dimensional (3D) images can overcome the limitations of two-dimensional images and are becoming more commonplace. This goal of this study is to analyze images of the right ventricle taken via 3D transesophageal echocardiography (TEE) during the LVAD implantation to help predict which patients are at higher risk of right ventricular failure within 14 days of the procedure.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients will be eligible to be included in the study if they receive either a left-sided:
- •HeartMate III (Thoratec, Pleasanton, CA)
- •HeartWare HVAD (HeartWare, Oakville CA)
- •Levitronix CentriMag (Levitronix LLC, Waltham, MA) LVAD.
Exclusion Criteria
- •Patients will be excluded if::
- •hemodynamic data needed to calculate PAPi or comprehensive echocardiographic images are missing
- •additional procedures affecting cardiac geometry and/or hemodynamic measurements, such as tricuspid, mitral, and/or aortic valve repair/replacement, were performed at the time of LVAD implantation
- •sternal closure at the end of the procedure is not possible
- •RV mechanical support was introduced concurrently with LVAD implantation
- •inadequate image quality required to obtain a 3D protocol
- •known contraindication to TEE
- •unexpected inability to advance probe into the mid-esophagus
Outcomes
Primary Outcomes
Right ventricular fractional area of change
Time Frame: 24 hours
Percentage change in the RV chamber area between end-diastole to end-systole
Right ventricular ejection fraction
Time Frame: 24 hours
Amount of blood being pumped out of the right ventricle each time it contracts.
Light ventricular end diastolic volume
Time Frame: 24 hours
Amount of blood in the heart's left ventricle just before the heart contracts
Tricuspid annular plane systolic excursion
Time Frame: 24 hours
Parameter of global right ventricular function
Left ventricular strain
Time Frame: 24 hours
Prognostic indicator of hypertensive heart failure
Right ventricular end systolic volume
Time Frame: 24 hours
Amount of blood in the heart's right ventricle just after the heart contracts
Right ventricular free wall strain
Time Frame: 24 hours
Prognostic indicator of pulmonary arterial hypertension
Right ventricular end diastolic volume
Time Frame: 24 hours
Amount of blood in the heart's right ventricle just before the heart contracts
Left ventricular end systolic volume
Time Frame: 24 hours
Amount of blood in the heart's left ventricle just after the heart contracts
Left ventricular ejection fraction
Time Frame: 24 hours
Amount of blood being pumped out of the left ventricle each time it contracts.
Secondary Outcomes
- Body Surface Area(1 day)
- Need for right ventricular mechanical support(14 days)
- Bilirubin(14 days)
- Gender(1 day)
- Pulmonary artery pulsatility index(14 days)
- Aspartate aminotransferase(14 days)
- Central venous pressure(14 days)
- Age(1 day)
- Need for pulmonary vasodilators(14 days)
- Need for vasopressors(14 days)
- Creatinine(14 days)